The Clinical Trials Regulation aims to create an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States. Intrinsic to this is the simplification of current rules, for example:

A streamlined application procedure via a single entry point - an EU portal and database, for all clinical trials conducted in Europe. Registration via the portal will be a prerequisite for the assessment of any application;

A single authorisation procedure for all clinical trials, allowing a faster and thorough assessment of an application by all Member States concerned, and ensuring one single assessment outcome and authorisation per Member State;

The extension of the tacit agreement principle to the whole authorisation process which will give sponsors and researchers, in particular SMEs and academics, more legal certainty;

Strengthened transparency for clinical trials data.

The Regulation entered into force on 16 June 2014 but will apply no earlier than 28 May 2016.

Transition between Directive 2001/20/EC and Regulation EU No 536/2014

Until the Clinical Trials Regulation EU No 536/2014 will become applicable, all clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive. This Directive will be repealed on the day of entry into application of the Clinical Trial Regulation. It will however still apply three years from that day to:

Clinical trials applications submitted before the entry into application (no earlier than 28 May 2016);

Clinical trials applications submitted within one year after the entry into application if the sponsor opted for old system.

The guidelines for the application of Clinical Trials Directive can be found here.

The relevant guidelines and recommendations are now being revised and updated to be in line with the changes and requirements of the Clinical Trials Regulation.

Revision of Clinical Trial Directive

Preparation of the Commission proposal

In its Communication of 10 December 2008 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on "Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector", the Commission announced that an assessment would be made of the application of the Clinical Trials Directive.

This assessment considered, in particular, various options for improving the functioning of the Clinical Trials Directive with a view to making legislative proposals, if appropriate, while taking the global dimension of clinical trials into account.

In 2009, a public consultation document along this line was published here. The responses have been published here. A summary document of the responses is available here.

A "roadmap" of the Commission impact assessment, setting out the main structure and the next steps, was made available here.

A "preliminary appraisal" of which option appeared to be the most suitable one to address some of the key concerns of the Clinical Trials Directive, on the basis of the current state of the impact assessment; and

the main figures used to evaluate the impacts of the different policy options.

The responses to this public consultation are published here. A summary of the responses is available here.

In addition, the transitory provisions of the Regulation offer the sponsors the possibility to choose between requirements of the Directive or the Regulation for 1 year from the entry into application of the regulation.